HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1

January 11, 2017 updated by: New York State Psychiatric Institute

HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs

The purpose of this study is to look at a program for women in drug abuse treatment designed to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors and reduce unprotected sexual risk behavior.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed trial is intended to test the effectiveness of a proven, manual driven, five-session safer sexual skills building group (SSB) intervention (Schilling et al., 1991; El Bassel and Schilling, 1992) for female patients in MMTP or in drug-free outpatient treatment. The effects of SSB will be compared to a standard group HIV education session (HE).

This study uses a 2-group, randomized, parallel-group design to compare a five-session safer sexual skills building group to a single 60-min HIV education session (control condition). The control condition is designed to standardize and simulate the usual care at community clinics.

Study Type

Interventional

Enrollment

541

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • Baart Cdp
    • Connecticut
      • New Britain, Connecticut, United States, 06051
        • Hartford Dispensary
    • New York
      • Staten Island, New York, United States, 10309
        • Staten Island University Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Addiction Drug Services
      • Raleigh, North Carolina, United States, 27604
        • South Light - Life Plus
      • Raleigh, North Carolina, United States, 27604
        • South Light - Wakeview
    • Ohio
      • Toledo, Ohio, United States, 43620
        • Comprehensive Addiction Services System
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Intensive Sub. Abuse TP
      • Philadelphia, Pennsylvania, United States, 19104
        • The Consortium
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • LRADAC-Lexington-Richmond Alcohol & Drug Council
    • Washington
      • Seattle, Washington, United States, 98134 1618
        • Evergreen Treatment Services
    • West Virginia
      • Huntington, West Virginia, United States, 25704
        • Prestera Center for Mental Health Svcs.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are invited to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
AIDS risk behavior

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Susan Tross, Ph.D., New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

June 8, 2004

First Submitted That Met QC Criteria

June 8, 2004

First Posted (Estimate)

June 9, 2004

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIDA-CTN-0019-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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